Evidence map›Paper›PMID 41109931›Full record

Trial reportClinical pharmacokinetics2026

Randomized, Double-Blind, Phase I Pharmacokinetic Study of Subcutaneous Recombinant Human Superoxide Dismutase (rhSOD) in Healthy Volunteers.

Valentin Al Jalali, Martin Bauer, Anselm Jorda, Felix Bergmann, Michael Wölfl-Duchek, Richard Partl, Brigitta Vcelar, Dietmar Katinger, Rawad Bashur, Harald Schnidar and 1 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Valentin Al JalaliDepartment of Clinical Pharmacology, Vienna University Hospital, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Martin BauerDepartment of Clinical Pharmacology, Vienna University Hospital, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Anselm JordaDepartment of Clinical Pharmacology, Vienna University Hospital, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Felix BergmannDepartment of Clinical Pharmacology, Vienna University Hospital, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Michael Wölfl-DuchekDepartment of Clinical Pharmacology, Vienna University Hospital, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Richard PartlDepartment of Therapeutic Radiology and Oncology, Comprehensive Cancer Center, Medical University of Graz, Graz, Austria.
Brigitta VcelarPolymun Scientific Immunbiologische Forschung GmbH, 3400, Klosterneuburg, Austria.
Dietmar KatingerPolymun Scientific Immunbiologische Forschung GmbH, 3400, Klosterneuburg, Austria.
Rawad BashurSCARLETRED Holding GmbH, 1030, Vienna, Austria.
Harald SchnidarSCARLETRED Holding GmbH, 1030, Vienna, Austria.
Markus ZeitlingerDepartment of Clinical Pharmacology, Vienna University Hospital, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. markus.zeitlinger@meduniwien.ac.at.ORCID 0000-0001-5500-5878

Funding

FFG 881646
6 · The paper itself

Abstract

backgroundExcessive production of reactive oxygen species (ROS), particularly superoxide anion (

methodsThis randomized, double-blind, placebo-controlled Phase I study evaluated the safety, tolerability, and pharmacokinetics of recombinant human Cu/Zn-SOD (rhSOD, SOD1) following subcutaneous administration of 40 mg every 12 hours in 16 healthy volunteers. Eight subjects were enrolled each in the single-dose (SD) and multiple-dose (MD) cohorts. Study assessments, including pharmacokinetic sampling, were performed for 72 (SD) or 92 hours (MD). Injection site erythema was objectively assessed using the innovative Standardized Erythema Value (SEV*) method, derived from photographs taken with Scarletred®Vision software (SCARLETRED Holding GmbH).

resultsNo serious adverse events occurred, and all treatment-related adverse events were mild. Injection site erythema was objectively assessed using the innovative standardized erythema value (SEV*) method, derived from photographs taken with Scarletred

conclusionsThese findings suggest that subcutaneous rhSOD may be a promising therapeutic candidate for conditions characterized by excessive

Indexed as

Superoxide DismutaseSuperoxide Dismutase-1AdultDouble-Blind MethodFemaleHealthy VolunteersHumansInjections, SubcutaneousMaleMiddle AgedRecombinant ProteinsYoung AdultRecombinant ProteinsSuperoxide DismutaseSuperoxide Dismutase-1

Identifiers

PMID41109931
PMCPMC12783157

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.